InfuseITRecalls & reported problems across all models
Salter Labs · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 3 models of InfuseIT by Salter Labs in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Jun 10, 2022 and Aug 27, 2025 — classified as 21 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (9 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported InfuseIT problems
Device problems
- Material Split, Cut or Torn9
- Material Integrity Problem6
- Tear, Rip or Hole in Device Packaging3
- Connection Problem2
- Disconnection2
- Burst Container or Vessel1
- Decrease in Pressure1
- Incomplete or Inadequate Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- Insufficient Information4
InfuseIT models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- InfuseIT ZIT-520INFUSOR, PRESSURE, FOR I.V. BAGS19 reports
- InfuseIT ZIT-3000INFUSOR, PRESSURE, FOR I.V. BAGS1 report
- InfuseIT ZIT-1020INFUSOR, PRESSURE, FOR I.V. BAGS1 report
Recent InfuseIT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
THE HOSPITAL REPORTED THAT THE JOINT BETWEEN THE AIRBAG AND THE SLEEVE DETACHED DURING USE UNDER APPROPRIATE PRESSURE WITH A 500 ML INFUSION BAG. WHILE NO PATIENT HARM OR INJURY WAS REPORTED, RECURRENCE OF THIS ISSUE COULD DELAY INFUSION THERAPY AND LEAD TO SERIOUS PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22910011 ↗MalfunctionAug 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED, THE ADHESIVE ON THE LEFT BAG AND SLEEVE PEELED OFF DURING USE WHICH MADE IT IMPOSSIBLE TO APPLY PRESSURE. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22850755 ↗MalfunctionAug 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED, THE ADHESIVE ON THE LEFT BAG AND SLEEVE PEELED OFF DURING USE WHICH MADE IT IMPOSSIBLE TO APPLY PRESSURE. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22845208 ↗MalfunctionJul 24, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT ALTHOUGH THE PRESSURE BAG HAD BEEN USED ONLY THREE TIMES, THE HOSPITAL REPORTED THAT THE ADHESIVE PART OF THE SLEEVE HAD COME OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22588561 ↗MalfunctionJul 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
AIRLIFE RECEIVED A SINGLE REPORT THAT REFERENCE A SINGLE INCIDENT THAT WAS REPORTATED: AFTER THE AIRBAG WAS PRESSURIZED TO 300 MMHG, THE END OF THE SLEEVE DETACHED FROM THE MAIN BODY OF THE AIRBAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22401215 ↗MalfunctionApr 17, 2025Connection Problem; Connection Problem
THE PRESSURE GAUGE AND CONNECTION TUBE CAME OFF. EVEN AFTER RECONNECTING, IT COMES OFF AGAIN IMMEDIATELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21861973 ↗MalfunctionMar 7, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
IT WAS REPORTED THAT THE CONNECTION TUBE AND PRESSURE GAUGE DETACHED DURING PATIENT USE. WHILE NO PATIENT HARM OR INJURY WAS REPORTED, RECURRENCE OF THIS ISSUE COULD POTENTIALLY DELAY INFUSION THERAPY AND LEAD TO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21554227 ↗MalfunctionJan 23, 2025Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn
IT WAS REPORTED BY THE CUSTOMER THAT: WE ARE EXPERIENCE PROBLEM WITH 500 ML BAGS THIS IS FROM DIFFERENT ORDERS BUT SAME PROBLEM SPLITTING ON THE SIDE OF GLUE/WELDING IS VERY DANGERS BECAUSE IS HAPPENING DURING PROCEDURE. THIS OCCURRED WITH THE SAME PRODUCT CODE ON 5 DIFFERENT DEVICES FROM THE SAME LOT. THEREFORE, 5 SEPARATE MDR REPORTS WILL BE SUBMITTED REGARDING THESE INCIDENTS. THIS IS THE FIRST OF THE FIVE: MDR NUMBERS WILL INCLUDE 3000219639-2025-00008, 3000219639-2025-00009, 3000219639-2025- 00007, 3000219639-2025-00010.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21225477 ↗MalfunctionJan 23, 2025Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn
IT WAS REPORTED BY THE CUSTOMER THAT: WE ARE EXPERIENCE PROBLEM WITH 500 ML BAGS THIS IS FROM DIFFERENT ORDERS BUT SAME PROBLEM SPLITTING ON THE SIDE OF GLUE/WELDING IS VERY DANGERS BECAUSE IS HAPPENING DURING PROCEDURE. THIS OCCURRED WITH THE SAME PRODUCT CODE ON 5 DIFFERENT DEVICES FROM THE SAME LOT. THEREFORE, 5 SEPARATE MDR REPORTS WILL BE SUBMITTED REGARDING THESE INCIDENTS. THIS IS THE FIRST OF THE FIVE: MDR NUMBERS WILL INCLUDE 3000219639-2025-00007, 3000219639-2025-00008, 3000219639-2025- 00010, 3000219639-2025-00011.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21225445 ↗MalfunctionJan 23, 2025Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn
IT WAS REPORTED BY THE CUSTOMER THAT: WE ARE EXPERIENCING A PROBLEM WITH 500 ML BAGS. THIS IS FROM DIFFERENT ORDERS BUT THE SAME PROBLEM - SPLITTING ON THE SIDE OF GLUE/WELDING. IT IS VERY DANGEROUS BECAUSE IT'S HAPPENING DURING PROCEDURES. THIS OCCURRED WITH THE SAME PRODUCT CODE ON 5 DIFFERENT DEVICES FROM THE SAME LOT. THEREFORE, 5 SEPARATE MDR REPORTS WILL BE SUBMITTED REGARDING THESE INCIDENTS. THIS IS THE FIRST OF THE FIVE: MDR NUMBERS WILL INCLUDE 3000219639-2025-00008, 3000219639-2025-00009, 3000219639-2025-00010, 3000219639-2025-00011.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21225443 ↗MalfunctionJan 23, 2025Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn
IT WAS REPORTED BY THE CUSTOMER THAT: WE ARE EXPERIENCE PROBLEM WITH 500 ML BAGS THIS IS FROM DIFFERENT ORDERS BUT SAME PROBLEM SPLITTING ON THE SIDE OF GLUE/WELDING IS VERY DANGERS BECAUSE IS HAPPENING DURING PROCEDURE. THIS OCCURRED WITH THE SAME PRODUCT CODE ON 5 DIFFERENT DEVICES FROM THE SAME LOT. THEREFORE, 5 SEPERATE MDR REPORTS WILL BE SUBMITTED REGARDING THESE INCIDENTS. THIS IS THE FIRST OF THE FIVE: MDR NUMBERS WILL INCLUDE 3000219639-2025-00008, 3000219639-2025-00009, 3000219639-2025- 00007, 3000219639-2025-00011.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21225442 ↗MalfunctionJan 23, 2025Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn
IT WAS REPORTED BY THE CUSTOMER THAT: WE ARE EXPERIENCE PROBLEM WITH 500 ML BAGS THIS IS FROM DIFFERENT ORDERS BUT SAME PROBLEM SPLITTING ON THE SIDE OF GLUE/WELDING IS VERY DANGERS BECAUSE IS HAPPENING DURING PROCEDURE. THIS OCCURRED WITH THE SAME PRODUCT CODE ON 5 DIFFERENT DEVICES FROM THE SAME LOT. THEREFORE, 5 SEPERATE MDR REPORTS WILL BE SUBMITTED REGARDING THESE INCIDENTS. THIS IS THE FIRST OF THE FIVE: MDR NUMBERS WILL INCLUDE 3000219639-2025-00007, 3000219639-2025-00009, 3000219639-2025- 00010, 3000219639-2025-00011.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21225440 ↗MalfunctionDec 10, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT THE CONNECTION TUBE AND PRESSURE GAUGE CAME OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20897749 ↗MalfunctionNov 26, 2024Mechanical Problem; Tear, Rip or Hole in Device Packaging; Mechanical Problem; Tear, Rip or Hole in Device Packaging
THE ADHESIVE AREA BETWEEN THE SLEEVE AND THE AIRBAG HAS COME UNDONE. THE SLEEVE PART HAS PEELED OFF. WE CHECKED THE DEVICE AT OUR END AND CONFIRMED THE ISSUE. WE HAVE RECEIVED TWO NEW COMPLAINTS FROM THE SAME FACILITY AS THE PREVIOUSLY REPORTED 24-I-163I. THE LOT IS ALSO THE SAME: 230200827. WE HAVE CONFIRMED THAT THE ADHESIVE AREA BETWEEN THE SLEEVE AND THE AIRBAG HAS COME UNDONE. WE CONSIDER THERE MAY BE AN ADHESIVE FAILURE BETWEEN THE SLEEVE AND THE AIRBAG. EVEN AFTER 2 HOURS OF PRESSURIZATION, THE PRESSURE GAUGE MAINTAINED A READING OF 300 MMHG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20788346 ↗MalfunctionOct 24, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE SLEEVE CAME OFF WHEN PRESSURIZED IT BY INJECTING SALINE SOLUTION BETWEEN THE AIRBAG AND THE SLEEVE. WE ARE USING IT ACCORDING TO THE INSTRUCTIONS, BUT SINCE THE SLEEVE CONTINUES TO BE DAMAGED, I WOULD LIKE TO KNOW THE CORRECT USAGE METHOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20527384 ↗
Other Salter Labs products
All Salter Labs devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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